NCT02082639 is a Phase 3 clinical trial of Cervarix™ in Infections, Papillomavirus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02082639?

NCT02082639 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02082639?

Interventions in NCT02082639: Cervarix™, Havrix.

What condition does NCT02082639 study?

NCT02082639 studies Infections, Papillomavirus.

Is NCT02082639 still recruiting?

NCT02082639 is currently withdrawn. Last updated 16 July 2015.

Last reviewed 2015-07-16 · How we verify

NCT02082639

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix™) (GSK-580299) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) (GSK-208109) in Healthy Female Adolescents Aged 9-14 Years

Withdrawn Phase 3 Last updated 16 July 2015

What this trial tests

Phase 3 trial testing Cervarix™ in Infections, Papillomavirus. Withdrawn.

Timeline

1 February 2015

Primary endpoint
1 August 2015

1 November 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Start date	1 February 2015
Primary completion	1 August 2015
Estimated completion	1 November 2015

Drugs / interventions tested

Cervarix™
Havrix — full drug profile →

Conditions studied

Infections, Papillomavirus — all drugs for Infections, Papillomavirus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 9 to 14, female only, with Infections, Papillomavirus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Time frame: One month after the second dose (Month 7)
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group
Time frame: One month after the second dose (Month 7)
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group
Time frame: One month after the second dose (Month 7)
Anti-HAV antibody titres in the HPV+HAV group and the HAV group
Time frame: One month after the second dose (Month 7)

Sponsor's own description

The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV vaccine according to 0, 6 month schedule, compared to the administration of either of these vaccines alone. The study will ascertain that the immune responses elicited to the two vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV vaccine are administered alone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Cervarix™

Trials testing the same drug.

NCT00546078 — Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America · Phase 2 · completed
NCT00578227 — Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy · Phase 3 · completed
NCT00250276 — Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation. · Phase 3 · completed
NCT00122681 — Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK · Phase 3 · completed

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02082639 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 16 July 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02082639.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing